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Pramipexole (Mirapexģ) for Parkinson's: Safety News from the FDA

- Sep 20 2012

The Parkinson's Disease Foundation® (PDF®) encourages all people with Parkinson's disease on the medication pramipexole (Mirapex®), especially those who have a history of heart failure, to discuss the following alert with their doctors:

The United States Federal Drug Administration (FDA), the governmental agency that monitors prescription drugs, alerted health care professionals on September 19, 2012, of a possible risk of heart failure in people receiving pramipexole (Mirapex®). No specific conclusion was drawn, but the FDA will monitor this problem and its possible relationship to the drug.

After reviewing the report, Christopher G. Goetz, M.D., Chair of the PDF Medical Policy Committee, commented: “The results so far do not establish any specific risk of heart failure from pramipexole exposure. In my view, the FDA is responsibly handling the concern with further research and is committed to informing healthcare professionals and patients of the issues it is investigating. Such action is appropriate in this era of transparency, so that everyone interested is well-informed.”

Based on Dr. Goetz’s comments, PDF encourages people with Parkinson's disease on pramipexole, especially those who have a history of heart failure, to discuss the report with their doctors. Further, PDF encourages those whose doctors suggest pramipexole as a possible treatment, to discuss this report as part of the decision to use the drug.

Importantly, the FDA has provided ways for patients and healthcare professionals to report problems or side effects from this and any other medication, so that patterns of problems can be followed carefully. Individuals can visit www.fda.gov/MedWatch/report.htm or call (800) 332-1088 to report such problems.

People with Parkinson's disease, family members or health care professionals who have additional questions can call PDF's toll-free HelpLine at (800) 457-6676 or download our 'Understanding Parkinson's Medications' fact sheet, to find out more about their medications and possible side effects.